Acute Coronary SyndromePhase 2NCT06533358
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
A Phase 2 study testing MT1002 Injection in people with Acute Coronary Syndrome, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- MT1002 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 27 Feb 2024to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged 18-85 years old (both 18 and 85 years old)
- Diagnosis of acute coronary syndrome (ACS)
- Subjects who will undergo PCI during hospitalization
- Able to understand and willing to sign written informed consent prior to undertaking any study-related activities
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment or be postmenopausal for at least 1 year, or permanently sterilized for ≥ 6 weeks. For women of childbearing potential and men with female partners of childbearing potential, effective contraception must be used if they are sexually active from the time of informed consent until 90 days after MT1002 administration
Who cannot join
- cardiogenic shock, or cardiopulmonary resuscitation (CPR）
- Suspicious aortic dissection, pericarditis, endocarditis
- Has any history of intracranial hemorrhage or structural abnormalities
- Transient ischemic attack, stroke within 6 months
- History of gastrointestinal or genitourinary bleeding within 1 month
- Major surgery within 1 month
Show all 23Show fewer
- The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
- Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening
- Prior (within 7 days prior to enrollment) or planned use of thrombolytic agents, bivalirudin, or fondaparinux. 12 hours before enrollment, unfractionated heparin or low molecular weight heparin was injected subcutaneously.
- Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days
- Anticipated need for oral anticoagulants within 3 days of dosing
- Severe uncontrolled hypertension persists even within 24 hours of adequate treatment
- According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc
- Known associated hematologic abnormalities
- Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of < 1 year
- Known severe liver disease
- Known hepatitis B and hepatitis C, HIV screening serology positive, except for the low viral replication phase.
- Known chronic kidney disease
- Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast agents.
- Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index within the range of 18.0~30.0kg/m2 (including boundary values)
- Subjects who have previously used MT1002.
- Unable to fully cooperate with the study protocol.
- Has any other medical or psychiatric illness that, in the opinion of the investigator, precludes participation in the study.
Trial locations and contacts
2 sites in 1 country.
NA NA NA contact
China2 sites, 2 recruiting
- Recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100029
Changsheng Ma, Medical phd, 13501373114, chshma@vip.sina.com
- Recruiting
Xianyang Hospital, Yan'an University
Xi'an, Shaanxi, 712000
Qiufang Lian
About this study
Official title: An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.
Read the detailed description
MT1002 is a novel 32-amino acid synthetic peptide aimed to combine molecular functions of both a direct thrombin inhibitor and a platelet glycoprotein IIb/IIIa receptor antagonist, indicated for use as an antithrombotic and anticoagulant in patients with ACS and in patients undergoing PCI.
This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.
- Conditions
- Acute Coronary Syndrome
- Being tested
- MT1002 Injection
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1002 InjectionDrug
Also called No other name
MT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI
| Study group | Role | What they receive |
|---|---|---|
| MT1002 Injection | Experimental | MT1002 is infused once only, once for 4h Receives: Drug: MT1002 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of subjects who achieved target ACT (200-300 s)
percentage of subjects achieving target ACT (200-300 s) among subjects receiving MT1002 (not switching to standard care) pre/intraoperatively and after successful PCI
Measured: Day 1, 24 hours （Day 2） to Day 30±2 after intravenous injection on Day 1
Major bleeding events
Adverse events (AEs): Major bleeding events (Bleeding Academic Research Consortium [BARC] type 3-5)
Measured: Day 1 to end of follow-up period (Day 30±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start27 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Medical phd, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533358
- Sponsor's protocol ID
- MT1002-II-C04
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
- ClinicalTrials.gov ID
- NCT06533358
- Acronym / sponsor ID
- MT1002-II-C04
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.
Detailed description
MT1002 is a novel 32-amino acid synthetic peptide aimed to combine molecular functions of both a direct thrombin inhibitor and a platelet glycoprotein IIb/IIIa receptor antagonist, indicated for use as an antithrombotic and anticoagulant in patients with ACS and in patients undergoing PCI.
This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT1002 Injection | Experimental | Drug: MT1002 InjectionMT1002 is infused once only, once for 4h |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged 18-85 years old (both 18 and 85 years old)
- Diagnosis of acute coronary syndrome (ACS)
- Subjects who will undergo PCI during hospitalization
- Able to understand and willing to sign written informed consent prior to undertaking any study-related activities
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment or be postmenopausal for at least 1 year, or permanently sterilized for ≥ 6 weeks. For women of childbearing potential and men with female partners of childbearing potential, effective contraception must be used if they are sexually active from the time of informed consent until 90 days after MT1002 administration
Key exclusion criteria (23 listed)
- cardiogenic shock, or cardiopulmonary resuscitation (CPR）
- Suspicious aortic dissection, pericarditis, endocarditis
- Has any history of intracranial hemorrhage or structural abnormalities
- Transient ischemic attack, stroke within 6 months
- History of gastrointestinal or genitourinary bleeding within 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1002 InjectionAlso: No other nameMT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI | Drug | MT1002 Injection |
Primary outcome
percentage of subjects who achieved target ACT (200-300 s)
Time frame: Day 1, 24 hours （Day 2） to Day 30±2 after intravenous injection on Day 1
percentage of subjects achieving target ACT (200-300 s) among subjects receiving MT1002 (not switching to standard care) pre/intraoperatively and after successful PCI
Major bleeding events
Time frame: Day 1 to end of follow-up period (Day 30±2)
Adverse events (AEs): Major bleeding events (Bleeding Academic Research Consortium [BARC] type 3-5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NA NA NA contact
Changsheng Ma, Medical phd principal investigator
Beijing Anzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT1002 Injection in people with Acute Coronary Syndrome, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changsheng Ma, Medical phd (13501373114, chshma@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of subjects who achieved target ACT (200-300 s) (time frame: Day 1, 24 hours （Day 2） to Day 30±2 after intravenous injection on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.